Document Control Administrator
- Provided support to the engineering/construction team and troubleshoot day-to-day activities within the document control group
- Assisted in training project personnel to use the electronic document/database management
- Administered EDMS; create new user accounts and assign passwords
- Communicated with all staff levels in a professional and effective manner
- Data entry, processing, and scanning of all project document types using a high-volume scanner and importing digital media with Adobe Capture program
- Performed quality check for data entered into the system
- Tracked responses to open action correspondence; created daily and monthly reports in Microsoft Excel and Access
- Supervised and worked closely with staff to achieve department and company goals
- Assisted department manager with administrative tasks and special projects
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Quality Assurance- Document Control Administrator
- Oversee and manage all Engineering Change Orders (ECO's). Evaluate and prioritize changes based on business and customer needs. Ensure critical timelines are met.
- Process and issue procedures including SOPs, specifications, manuals, assembly instructions, test procedures and drawings in accordance with current practices, ISO, QSR, 13485, and cGMPs.
- Issue and follow-up on CAPAs and Deviations.
- Track, maintain and update document master list, change control, deviation and CAPA logs. Prepare quarterly trend analysis and metrics for Quality Meetings.
- Assures that all documents are reviewed on a periodic basis for continuing compliance.
- Coordinates information flow between the Quality Document System and other Quality Systems and Corporate depts.
- Conduct change control meetings. Responsibilities include scheduling meetings, creating agendas and assigning and following up on action items.
- Developed and implemented training sessions for updates to site wide change control process. Train new employees on documentation procedures.
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QA Manager / Document Control Administrator
- Responsible for the continuous improvement of the company's ISO9001 Quality Management System and serve as the ISO9001 Management representative.
- Perform all document and data control per ISO9001 requirements.
- Provide leadership and direction for the Quality Assurance Department, including managing four Quality Technicians.
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